Drug updated on 4/18/2024
| Dosage Form | Injection (subcutaneous; 1.75 mg/0.3 mL) |
| Drug Class | Melanocortin receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance.
Summary
- Bremelanotide (Vyleesi) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It has demonstrated statistically significant improvements in sexual desire and reduced distress associated with low desire across various prespecified subgroups, including age, weight, BMI subgroups, and baseline bioavailable testosterone quartiles.
- The analysis was based on four randomized controlled trials. These studies showed Vyleesi's efficacy through significant increases in the Female Sexual Function Index desire domain scores and decreases in Female Sexual Distress Scale-Desire/Arousal/Orgasm Item 13 scores.
- Subgroup considerations revealed that Vyleesi was effective even among participants not taking hormonal contraceptives. Its consistent efficacy across diverse subgroups suggests broad applicability within its target population.
- In terms of the safety profile, a 52-week open-label extension of the RECONNECT phase 3 trials evaluated the long-term safety of Vyleesi, without observing any new safety signals. Common treatment-emergent adverse events included nausea (40.4%), flushing (20.6%), and headache (12%).
- Compared to placebo groups during clinical trials, participants using Vyleesi experienced more instances of nausea, flushing, and headaches, but these side effects were generally tolerable; the only severe event reported by more than one participant was nausea.
- While specific comparative data to other drugs were not provided in the studies reviewed here, the available information suggests that despite some tolerability concerns such as nausea or headaches, which appeared more frequently than in the placebo group, no new safety concerns over long-term use were revealed, making Bremelanotide (Vyleesi) a relatively safe option within its indication area.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vyleesi (bremelanotide) Prescribing Information. | 2021 | Palatin Technologies Inc., Cranbury, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Prespecified and integrated subgroup analyses from the RECONNECT Phase 3 studies of bremelanotide. | 2022 | Journal of Women’s Health |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Safety profile of bremelanotide across the clinical development program. | 3,500Subjects F: null% M: null% | 2022 | Journal of Women’s Health |
| Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. | 1,267Subjects F: 100% M: 0% | 2019 | Obstetrics & Gynecology |
| Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. | 1,247Subjects F: 100% M: 0% | 2019 | Obstetrics & Gynecology |
Sex Distribution:
F:%
M:%
3500Subjects
Year:
2022
Source:Journal of Women’s Health
Sex Distribution:
F:100%
M:0%
1267Subjects
Year:
2019
Source:Obstetrics & Gynecology
Document Title
Sex Distribution:
F:100%
M:0%
1247Subjects
Year:
2019
Source:Obstetrics & Gynecology